Peritoneal Carcinomatosis study: Radspherin
Official title A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery
ClinicalTrials.gov ID: NCT06504147
What this study is testing
What is Radspherin?
Radspherin is an investigational liquid medicine being studied as a potential treatment for peritoneal carcinomatosis. It is designed to deliver a short-lived radioactive substance directly to the abdominal cavity to target cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a single dose of a radiation drug is safe and effective for people with advanced ovarian cancer.
- Who it's for
- People with advanced ovarian, fallopian tube, or peritoneal cancer that has spread to the lining of the abdomen.
- What's involved
- Participants get one injection of the drug into the abdomen before starting chemotherapy and surgery.
- Time commitment
- The study involves the time needed for chemotherapy, surgery, and follow-up visits.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP).
- Female of age ≥ 18 years.
- Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO...
- Peritoneal and other metastases eligible for IDS to no residual tumour.
- Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy.
You likely can't join if
- Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.
- Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient...
- Epithelial borderline tumours, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumours, non-epithelial ovarian...
- Symptomatic central nervous system metastasis.
- Another primary malignancy within the past 3 years (except for non melanoma skin cancer, cutaneous melanoma stage 1, cervical cancer in situ or FIGO...
- Prior abdominal/pelvic radiotherapy.
See the full eligibility criteria
- Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP).
- Female of age ≥ 18 years.
- Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB/C or IV).
- Peritoneal and other metastases eligible for IDS to no residual tumour.
- Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy.
- Confirmed HR proficient tumour.
- Received NACT (numbers of cycles as per investigator's discretion) with regress or stable disease on diagnostic imaging and assessed to be operable to R0 pre-surgery.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 2 and patient fit enough to undergo IDS and further treatment according to standard of care.
- Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml/min or measured creatinine clearance ≥ 40 ml/min.
- Serum bilirubin \< 1.5 x upper limit of normal (ULN), and
- Aspartate transaminase and alanine transaminase ≤ 3 x ULN.
- Absolute neutrophil count ≥ 1.0 x 10\^9/l, and
- Platelets ≥ 100 x 10\^9/l, and
- Haemoglobin ≥ 9 g/dL.
- For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.
- For females of childbearing potential agreement to use at least one of the following highly effective (failure rate \< 1%) methods of contraception during the treatment period and for at least 9 months if they receive...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g.
- Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment.
- Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have...
- Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.
- Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images.
- Epithelial borderline tumours, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumours, non-epithelial ovarian malignancies, carcinosarcoma and neuroendocrine tumours or recurrent ovarian...
- Symptomatic central nervous system metastasis.
- Another primary malignancy within the past 3 years (except for non melanoma skin cancer, cutaneous melanoma stage 1, cervical cancer in situ or FIGO 2023 Stage IA1 or IA3 prior or synchronous endometrial cancer).
- Prior abdominal/pelvic radiotherapy.
- Disease progression during NACT.
- Pregnant or lactating (nursing) women.
- Active infections requiring antibiotics, and/or physician monitoring, or recurrent fever \> 38.0⁰C associated with a clinical diagnosis of active infection.
- Active liver disease with positive serology for active hepatitis B, hepatitis C or known human immunodeficiency virus (HIV).
- Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease.
- Any condition or illness that, in the opinion of the investigator or the medical monitor, would compromise the safety of the patients or interfere with the evaluation of the safety of the investigational medicinal...
- In the investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent.
- Administration of an investigational medicinal product within 4 weeks, or at least 5 times the half life, prior to enrolment.
- Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the surgery.
- Treatment with bevacizumab within 5 weeks prior to IDS.
- Known hypersensitivity to any of the excipients of the study drug.
The study team makes the final eligibility decision.
Where it is enrolling
- Tampa, Florida, United States
- Leuven, Belgium
- Roma, Italy
- Oslo, Norway
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
- Valencia, Spain
- London, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tampa, Florida, United States; Leuven, Belgium; Roma, Italy; Oslo, Norway; Barcelona, Spain; Madrid, Spain and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.